Nutraceuticals: Introduction, Classification and Legal Aspects | Biology

In this article we will discuss about:- 1. Introduction to Nutraceuticals 2. Classification of Nutraceuticals 3. Current Status and Legal Aspects.

Introduction to Nutraceuticals:

Major scientific and engineering advances in recent decades have led to an increase in the development of expensive, high-technology medical and surgical procedures and drug therapies. At the same time, however, there has been an increase in the number of people turning to alternative medical therapies, which emphasize the importance of a ‘good diet’ in maintaining and restoring health.

The term “nutraceutical” was coined from “nutrition” and “pharmaceutical” in 1989, by Stephen DeFelice, MD, founder and chairman of the Foundation for Innovation in Medicine.

A nutraceutical can be defined as “any substance that may be considered a food or part of a food and provides medical or health benefits, including the prevention and treatment of disease. Such products may range from isolated nutrients, dietary supplements and diets to genetically engineered ‘designer’ foods, herbal products and processed foods such as cereals, soups and beverages.” Such foods are commonly referred to as functional foods, signifying that these foods and/or their components may provide a health benefit that goes beyond basic nutrition.

At present, there are no universally accepted definitions for nutraceuticals and functional foods, although commonality clearly exists between the definitions offered by different health-oriented professional organizations. According to the American Dietetic Association, the term “functional” implies that the food has some identified value leading to health benefits, including reduced risk of disease, for the person consuming it.

Functional foods include everything from natural foods, such as fruits and vegetables endowed with antioxidants and fibre, to fortified and enriched foods, such as orange juice with added calcium or additional carotenoids, to formulated ready-to-drink beverages containing antioxidants and immune-supporting factors. The Nutrition Business Journal states that it uses the term, nutraceutical, for anything that is consumed primarily or particularly for health reasons. Based on that definition, a functional food would be a kind of nutraceutical.

On the other hand, Health Canada states that a nutraceutical is a product that is “prepared from foods, but sold in the form of pills or powders (potions), or in other medicinal forms not usually associated with foods. A nutraceutical is demonstrated to have a physiological benefit or provide protection against chronic disease.”

Classification of Nutraceuticals:

Nutraceuticals can be classified on the basis of food source (Table 13.1), mechanism of action (Table 13.2), and chemical nature (Table 13.3).

Current Status and Legal Aspects of Nutraceuticals:

The nutraceutical industry has emerged as an important part of the food industry. With high economic growth, increasing income and changing lifestyles, the market is growing enormously. Globally, the nutraceutical market was placed at 65 billion dollars in 2002 and was expected to grow to 250 billion dollars by 2005. In India, this market is at about Rs. 1, 600 crore at present, with an annual growth rate of 25%.

In developed countries, predictable factors have been largely responsible for encouraging the growth of the nutraceutical industry. High disposable incomes, changing lifestyles with unhealthy eating habits, increasing incidence of health problems, an increasingly larger aging populations with unique dietary needs to maintain health, etc., have all prompted the development of new nutritional solutions, especially the use of nutraceuticals.

Therefore, there is a significant correlation between the growth of nutritional ingredients and demographic issues and confidence in the growth of nutraceutical products over the next 20 years.

Although this industry is also expanding in developing countries, it is difficult to predict its growth rate. Some of the reasons for this are – high population, disparity in levels of disposable income, spectrum of malnutrition including over- and under-nutrition etc. Notwithstanding the above, the Indian nutraceutical industry also has great prospects.

Over the last decade, a wide range of products have been available, giving an insight into the potential for tremendous growth. On the one hand, a booming economy has resulted in an overall increase in disposable incomes. Added to this, unhealthy eating habits coupled with a sedentary lifestyle have led to increased incidence of diet and related health issues.

On the other hand, there is growing awareness on the importance of nutrition and diet for long-term good health. These have contributed to favourable market conditions for the nutraceutical industry in India. Apart from this, India has other advantages like well-qualified and intelligent human resources for setting up R&D facilities of international standards.

The country is also a cost-effective source of sophisticated raw materials, due to technological advances in areas like fermentation processes, plant extraction and chemical synthesis. These converging economic and demographic trends in India have laid the groundwork for opportunities in the nutraceutical industry.

While prospects are high for this industry, India faces certain challenges too. The supply chain is a long one and is further affected by poor infrastructure in terms of roads, cold chain facilities and storage conditions. The wastage of fresh food is as high as 50% due to lack of infrastructure facilities.

Despite surplus food, the productivity of agricultural/horticultural crops is very low and the land-holding pattern is fragmented. In addition to this, the taxes levied on packaged and branded foods are very high – about 30% in India. In comparison, the taxes in EU countries are below 10% and even in other Asian countries like China, it is only 13%. All these disadvantages hinder India from gaining a competitive edge in the global market.

The regulatory framework in India also needs the attention of the relevant authorities. Globally, the regulatory authorities are aware of the changing needs of consumers and proactively protect consumers by amending existing laws to accommodate changes. NLEA (Nutrition Labelling and Education Act) of 1990 and DSHEA (Dietary Supplement and Health Education Act of 1994 are fine examples of this in the USA.

Similarly, the FOSHU Act (Foods of special Health Uses) was introduced in Japan much earlier. But the scenario in India is very different. Old laws such as the Prevention of Food Adulteration Act, 1954, which regulates packaged foods, still exist.

In addition, manufacturers need to abide by many other cumbersome laws [Fruit Products Order, 1955 (FPO); Vegetable Oils Products (Regulation) Order, 1998 (VOP); Agricultural Produce (Grading and Marking) Act, 1937 (as amended up to 1986) and General Grading and Marking Rules, 1986 and 1988 (AGMARK)].

In India, there is lack of clarity in classifying items into functional foods and nutraceuticals. This causes confusion among the regulators. At times, the drug regulators are tempted to classify these products as drugs. This has resulted in trouble for genuine manufacturers. Proper legislation is the need of the hour.

The Government of India has taken certain welcome steps like the amendment of the PFA (Prevention of Food Adulteration Act) which defines “Food for special dietary uses”. Another revolutionary step that is being planned is to introduce a Food Safety and Standards Act. This will replace the old PFA with new legislation. The new Act will take India on to the path of a new regulatory framework to make it capable of taking on global competition.